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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1519_Библиотеки_им_академика_М_И_Перельмана.pdf
444
permanent implant, 31 % failed to reach the 50 % reduction threshold defined as
success. Younger age was related to success with temporary stimulation. A neuro-
logic disorder as etiology for incontinence was related to success with permanent
implant.
SNS was compared to optimal medical therapy in a randomized study including
60 patients with severe fecal incontinence in each arm [36]. Ninety percent (54
patients) in the SNS group reached the threshold of 50 % improvement of inconti-
nent episodes; 53 were implanted with 47 % reporting perfect continence. There
were no septic complications at a mean follow up of 12 months. There was no sig-
nificant improvement reported in the medical therapy group.
A short version Cochrane review of SNS for fecal incontinence published in
2008 included two small crossover studies [37]. The authors concluded that while
results were very limited, it suggested that SNS could improve fecal continence in
selected patients. However, it was also noted that temporary percutaneous stimula-
tion did not always successfully identify those for whom a permanent implant
would be beneficial, exposing some group of patients to having an ineffective inva-
sive procedure and foreign body implant.
Several longer term reports on SNS results from a multi-institutional study group
illuminate the risk of adverse events and significant complications requiring reop-
eration. The most common device or therapy related adverse events were implant
site pain (28 %), paresthesia (15 %), change in stimulation sensation (12 %), and
infection (10 %) [38]. Of particular note, infection carries a 50 % risk of permanent
system explantation [39]. Additionally, 36 % of patients followed for at least 5 years
required a device revision, replacement, or explant [40].
The most recent Cochrane review of SNS for fecal incontinence included four
crossover trials and two parallel group trials. The authors concluded that the limited
evidence from the included trials suggested SNS could improve continence in a
proportion of patients with fecal incontinence. However, authors also noted the fre-
quency of reported adverse events ranged from 15 to 21 % [41].
Discussion
Direct comparison of data regarding anal sphincter repair and SNS is difficult. Most
of the studies of sphincteroplasty are small, single institution, often retrospective,
and the populations included and measures used to quantify outcome are heteroge-
neous. This is underscored by the conclusions of the most recent Cochrane review
of surgery for fecal incontinence in adults, which comments on the lack of high
quality randomized controlled trials for fecal incontinence surgery [42]. While short
to medium term outcomes for anal sphincter repair are good, function deteriorates
over time. However, long term outcomes still seem at least as good as the definition
of SNS “success”, and patient quality of life and reported satisfaction remain high.
Many of the published studies of SNS in fecal incontinence are small crossover
or parallel trials, with a lack of comparison to anal sphincter repair. The included
J. Rakinic and V.P. Poola
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445
populations are heterogeneous, and the outcome measures often differ from those
used in the evaluation of anal sphincter repair outcomes. The frequency with which
patients achieve the 50 % reduction threshold to proceed to permanent electrode
implant varies, with predictive factors not clearly identified, and success with tem-
porary implant does not guarantee success with permanent implant. Finally, the risk
of complications leading to reoperation appears to be 15–20 %.
Conclusions
A. In patients with a demonstrated sphincter defect, if best conservative manage-
ment is not sufficient for control of moderate to severe fecal incontinence symp-
toms, sphincteroplasty should be strongly considered. Discussion of possible
worse short and long term outcomes should be undertaken with patients over
age 50 (or 60), and possibly also for those with pudendal neuropathy. Grade of
strength of recommendation is STRONG.
B. Outcomes of sphincteroplasty are at least as good as SNS outcomes with fewer
complications requiring reoperation. Grade of strength of recommendation is
STRONG.
C. Those who fail sphincteroplasty can be considered for repeat sphincteroplasty
with the expectation of reasonable results. Grade of recommendation is
CONDITIONAL.
D. Sphincteroplasty is unlikely to produce improvement for flatus incontinence.
References
1. Naimy N, Lindam AT, Bakka A, Faerden AE, et al. Biofeedback vs. electrostimulation in the
treatment of postdelivery anal incontinence: a randomized clinical trial. Dis Colon Rectum.
2007;50(12):2040–6.
2. Terra MP, Dobben AC, Berghmans B, Deutekom M, et al. Electrical stimulation and pelvic
floor muscle training with biofeedback in patients with fecal incontinence: a cohort study of
281 patients. Dis Colon Rectum. 2006;49(8):1149–59.
3. Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incon-
tinence in adults. Cochrane Database Syst Rev. 2012;(7):CD002111. doi:10.1002/14651858.
CD002111.pub3.
4. Guillemot F, Bouche B, Gower-Rousseau C, Chartier M, et al. Biofeedback for the treatment
of fecal incontinence. Long term clinical results. Dis Colon Rectum. 1995;38(4):393–7.
5. Terra MP, Deutekon M, Dobben AC, Baeten CG, et al. Can the outcome of pelvic floor reha-
bilitation in patients with fecal incontinence be predicted? Int J Colorectal Dis.
2008;23(5):503–11.
6. Pucciani F, Raggioli M, Gattai R. Rehabilitation of fecal incontinence: what is the influence of
anal sphincter lesions? Tech Coloproctol. 2013;17(3):299–306.
7. Dehli T, Stordahl A, Vatten LJ, Romundstad PR, et al. Sphincter training or anal injections of
dextranomer for the treatment of anal incontinence: a randomized trial. Scand J Gastroenterol.
2013;48(3):302–10.
39 When Is an Anal Sphincter Repair Indicated?
446
8. Abbas MA, Tam MS, Chun LJ. Radiofrequency treatment for fecal incontinence: is it effective
long-term? Dis Colon Rectum. 2012;55(5):605–10.
9. Fleshman JW, Peters WR, Shemesh EI, Fry RD, Kodner IJ. Anal sphincter reconstruction:
anterior overlapping muscle repair. Dis Colon Rectum. 1991;34:739–43.
10. Wexner SD, Marchetti F, Jagelman DG. The role of sphincteroplasty for fecal incontinence
reevaluated: a prospective physiologic and functional review. Dis Colon Rectum.
1991;34:22–30.
11. Engel AF, van Baal SJ, Brummelkamp WH. Late effects of anterior sphincter plication for
traumatic faecal incontinence. Eur J Surg. 1994;160:633–6.
12. Oliveira L, Pfeifer J, Wexner SD. Physiological and clinical outcome of anterior sphinctero-
plasty. Br J Surg. 1996;83:502–5.
13. Felt-Bersma RJ, Cuesta MA, Koorevar M. Anal sphincter repair improves anorectal function
and endosonographic image. A prospective clinical study. Dis Colon Rectum.
1996;39:878–85.
14. Nikiteas N, Korsgen S, Kumar D, Keighley MR. Audit of sphincter repair. Factors associated
with poor outcome. Dis Colon Rectum. 1996;39:1164–70.
15. Sitzler PJ, Thomson JP. Overlap repair of damaged anal sphincter. A single surgeon’s series.
Dis Colon Rectum. 1996;39:1356–60.
16. Ternent CA, Shashidharan M, Blatchford GJ, Christensen MA, Thorson AG, Sentovich
SM. Transanal ultrasound and anorectal physiology findings affecting continence after sphinc-
teroplasty. Dis Colon Rectum. 1997;40:462–7.
17. Zorcolo L, Covotta L, Bartolo DC. Outcome of anterior sphincter repair for obstetric injury:
comparison of early and late results. Dis Colon Rectum. 2005;48:524–31.
18. Barisic GI, Krivokapic ZV, Markovic VA, Popovic MA. Outcome of overlapping anal sphinc-
ter repair after 3 months and after a mean of 80 months. Int J Colorectal Dis. 2006;21:52–6.
19. Halverson AL, Hull TL. Long term outcome of overlapping anal sphincter repair. Dis Colon
Rectum. 2002;45:345–8.
20. Bravo Gutierrez A, Madoff RD, Lowry AC, Parker SC, Buie WD, Baxter NN. Long term
results of anterior sphincteroplasty. Dis Colon Rectum. 2004;47:727–31.
21. Maslekar S, Gardiner AB, Duthie GS. Anterior anal sphincter repair for fecal incontinence:
good longterm results are possible. J Am Coll Surg. 2007;204:40–6.
22. Mevik K, Norderval S, Kileng H, Johansen M, Vonen B. Longterm results after anterior
sphincteroplasty for anal incontinence. Scand J Surg. 2009;98:234–8.
23. Oom DM, Gosselink MP, Schouten WR. Anterior sphincteroplasty for fecal incontinence: a
single center experience in the era of sacral neuromodulation. Dis Colon Rectum.
2009;52:1681–7.
24. Zutshi M, Tracey TH, Bast J, Halverson A, Na J. Ten year outcome after anal sphincter repair
for fecal incontinence. Dis Colon Rectum. 2009;52:1089–94.
25. Grey BR, Sheldon RR, Telford KJ, Kiff ES. Anterior anal sphincter repair can be of long term
benefit: a 12-year case cohort from a single surgeon. BMC Surg. 2007;7:1.
26. El-Gazzaz G, Zutshi M, Hannaway C, Gurland B, Hull T. Overlapping sphincter repair: does
age matter? Dis Colon Rectum. 2012;55:256–61.
27. Lehto K, Hyoty M, Collin P, Huhtala H, Aitola P. Seven year follow-up after anterior sphincter
reconstruction for faecal incontinence. Int J Colorectal Dis. 2013;28:653–8.
28. Malouf AJ, Norton CS, Engel AF, Nicholls RJ, Kamm MA. Long term results of overlapping
anterior anal-sphincter repair for obstetric trauma. Lancet. 2000;355:260–5.
29. Donnelly V, O’Conell PR, O’Herlihy C. The influence of oestrogen replacement on faecal
incontinence in postmeopausal women. Br J Obstet Gynaecol. 1997;104:311–5.
30. Londono-Schimmer EE, Garcia-Duperly R, Nicholls RJ, Ritchie JK, Hawley PR, Thomson
JP. Overlapping anal sphincter repair for faecal incontinence due to sphincter trauma: five year
follow-up functional results. Int J Colorectal Dis. 1994;9:110–3.
31. Vaizey CJ, Norton C, Thornton MJ, Nicholls RJ, Kamm MA. Long term results of repeat
anterior anal sphincter repair. Dis Colon Rectum. 2004;47:858–63.
J. Rakinic and V.P. Poola
www.ebook3000.com
447
32. Giordano P, Renzi A, Efron J, Gervaz P, Weiss EG, Nogueras JJ, Wexner SD. Previous sphinc-
ter repair does not affect the outcome of repeat repair. Dis Colon Rectum. 2002;45:635–40.
33. Hong KD, da Silva G, Wexner SD. What is the best option for failed sphincter repair?
Colorectal Dis. 2014;16:298–303.
34. Hong K, Dasilva G, Dollerschell JT, Maron D, Wexner SD. Redo sphincteroplasty: are the
results sustainable? Gastroenterol Rep (Oxf). 2016;4:39–42.
35. Gourcerol G, Gallas S, Michot F, Denis P, Leroi AM. Sacral nerve stimulation in fecal incon-
tinence: are there factors associated with success? Dis Colon Rectum. 2007;50:3–12.
36. Tjandra JJ, Chan MK, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective
than optimal medical therapy for severe fecal incontinence: a randomized controlled study. Dis
Colon Rectum. 2008;51:494–502.
37. Mowatt G, Glazener C, Jarrett M. Sacral nerve stimulation for fecal incontinence and constipa-
tion in adults: a short version Cochrane review. Neurourol Urodyn. 2008;27:155–61.
38. Mellgren A, Wexner SD, Coller JA, Devroede G, Lerew DR, Madoff RD, Hull T, SNS Study
Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis
Colon Rectum. 2011;54:1065–75.
39. Wexner SD, Hull T, Edden Y, Coller JA, Devroede G, McCallum R, Chan M, Ayscue JM,
Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P,
Nagle D, Madoff RD, Lerew DR, Mellgren A. Infection rates in a large investigational trial of
sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. 2010;14:1081–9.
40. Hull T, Giese C, Wexner SD, Mellgren A, Devroede G, Madoff RD, Stromberg K, Coller JA,
SNS Study Group. Long-term durability of sacral nerve stimulation therapy for chronic fecal
incontinence. Dis Colon Rectum. 2013;56:234–45.
41. Thaha MA, Abukar AA, Thin NN, Ramsanahie A, Knowles CH. Sacral nerve stimulation for
faecal incontinence and constipation in adults. Cochrane Database Syst Rev.
2015;(8):CD004464. doi:10.1002/14651858.CD004464.pub3.
42. Brown SR, Wadhawan H, Nelson RL. Surgery for faecal incontinence in adults. Cochrane
Database Syst Rev. 2013;(7):CD001757. doi:10.1002/14651858.CD001757.pub4.
39 When Is an Anal Sphincter Repair Indicated?
Part VII
Quality Improvement
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451© Springer International Publishing Switzerland 2017
N. Hyman, K. Umanskiy (eds.), Difficult Decisions in Colorectal Surgery,
Difficult Decisions in Surgery: An Evidence-Based Approach,
DOI 10.1007/978-3-319-40223-9_40
Chapter 40
Checklists in Surgery
Eric A. Sparks and Harry T. Papaconstantinou
Introduction
Nearly two decades have passed since the publication of To Err is Human [1], and
there has been considerable subsequent interest in research and interventions to
describe and prevent health care associated injuries and improve patient outcomes.
The WHO launched its “Safe Surgery Saves Lives” campaign in 2008 as a means to
prevent unnecessary mortality and improve outcomes for surgical patients [2]. This
program resulted in the WHO Surgical Safety Checklist (SSC) [3], which has been
widely considered successful in reducing the rates of perioperative complications
and mortality. Use of the WHO and similar checklists has now become widespread.
However, not all investigations have confirmed their utility and checklists have cer-
tainly met some resistance wherever implemented. The purpose of this chapter is to
(1) summarize the current body of literature describing the use of surgical checklists
and (2) offer expert opinion as to what role checklists may serve for the practicing
colorectal surgeon.
E.A. Sparks, MD
Department of Surgery, Baylor Scott & White Healthcare, Scott & White Memorial Hospital,
Temple, TX, USA
H.T. Papaconstantinou, MD (
*)
Department of Surgery, Baylor Scott & White Healthcare, Texas A&M University College of
Medicine, Baylor Scott & White Memorial Hospital,
2401 South 31st Street, Temple, TX 76508, USA
e-mail: hpapaconstantinou@sw.org
452
Methods and Search Strategy
Prior to literature search, a PICO table and four specific questions were formulated
as shown below. The literature review was performed under guidelines suggested by
the GRADE approach. A systematic literature search was undertaken using
MEDLINE via PUBMED and the Cochrane Library. Publications in English dated
from January 2000 to May 2015 were included. MeSH search terms and their com-
bination included “checklist”, “safety”, “randomized control trial”, “mortality”,
“morbidity”, “surgery”, and “colorectal.” Specific database functions such were
used to maximize the search. Reference lists of retrieved articles were further
screened for additional publications. All identified studies involving evaluation of
implementation of, attitudes towards, or outcomes following use of surgical safety
checklists were reviewed in depth. The PICO table defined below was used to guide
literature search and interpretation of findings.
Question 1: Do surgical checklists reduce perioperative morbidity & mortality?
Question 2: Do surgical checklists have other costs or benefits?
Question 3: Are there costs or barriers to use of surgical checklists?
Question 4: Do surgical checklists offer specific benefits to colorectal surgery?
P (patients) I (intervention) C (comparator) O (outcomes)
All adult patients
undergoing colon
resection
Use of checklists for
quality improvement
Historical management
systems without
checklists
Mortality
Morbidity
Errors (wrong site,
procedure, etc)
Cost
Efficiency
Attitudes and barriers
Results
Question 1: Do surgical checklists reduce perioperative morbidity & mortality?
The WHO surgical safety checklist was implemented in 2008. In 2009, Haynes’
et al. published a landmark study which began a growing mountain of evidence to
support the use of these checklists [2]. This study prospectively collected data on
approximately 4000 patients from a diverse group of eight hospitals worldwide
before and after implementation of the SSC. The authors demonstrated reductions
in death (1.5–0.8 %, p = 0.003) and inpatient complications (11.0–7.0 %, p < 0.001)
with checklist use. Many of the studies that followed have been prospective or ret-
rospective observational studies to evaluate the results of SCC implementation in
more specific clinical settings (Table 40.1).
While no prospective randomized control studies have been (or likely will be)
done, Gillespie et al. performed a robust meta-analysis including seven prospective
E.A. Sparks and H.T. Papaconstantinou
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453
Table 40.1 Question 1: Do surgical checklists reduce perioperative mortality & mortality?
Author/year Study design
n/type of
procedure Outcome measures Conclusions
Quality of
evidence
Gillespie et al. (2014) [4] Meta-analysis 37,339/general Major complications,
mortality, minor
complications
Use of a SSC reduces all complications,
wound infections, blood loss. No
significant reductions in mortality,
pneumonia, or unplanned reoperation.
High
Kwok et al. (2013) [5] Prospective cohort 2145/general Process adherence,
major 30 days
complications,
intraoperative
hypoxemia
SSC implementation resulted in a
decrease in overall, infectious, and
noninfectious complications in a
resource-limited setting
Moderate
Bliss et al. (2012) [6] Prospective cohort 319/general Checklist completion,
30 days morbidity,
adverse events
Implementation of SSC results in
reduction in adverse events from
expected (NSQIP data) rates.
Moderate
Weiser et al. (2010) [7] Prospective cohort 1750/general 30 day morbidities and
mortality
SSC implementation reduces overall
complication rate and mortality
Moderate
Haynes et al. (2009) [2] Prospective cohort 7688/general 30 day morbidities and
mortality
SSC implementation significantly
reduced inpatient morbidity and
mortality in a group of 8 international
hospitals
Moderate
Haugen et al. (2015) [8] Prospective cohort 2212/general 30 day morbidities and
mortality
SSC implementation significantly
reduced inpatient morbidity and
mortality using a model to adjust for
possible confounders
Moderate
(continued)
40 Checklists in Surgery
454
Author/year Study design
n/type of
procedure Outcome measures Conclusions
Quality of
evidence
Tillman et al. (2013) [9] Prospective cohort 824/general Compliance with SCIP
Measures
Implementation of SSC improves
compliance with SSI reduction
strategies and may reduce SSI rates in
colorectal procedures
Moderate
Askarian et al. (2011) [10] Prospective cohort 294/general Any complication SSC implementation decreases
perioperative complications in a small
Iranian hospital
Moderate
Sewell et al. (2011) [3] Prospective cohort 965/
orthopedics
Any complication,
mortality
SSC was not associated with a
significant reduction in early
complications and mortality in patients
undergoing orthopaedic surgery
Moderate
Yuan et al. (2012) [11] Prospective cohort 481/general Any complication,
mortality
SSC implementation is associated with
variable improvements in surgical
process compliance and surgical
outcomes
Moderate
McCarroll et al. (2015) [12] Retrospective
cohort
89/
laparoscopic/
robotic
30 day readmission
Length of stay
Operative time
Decreased readmissions (13.5 % vs
4.1 %), no difference in LOS or OR
time
Very low
Garcia-Paris et al. (2015) [13] Retrospective
cohort
134/podiatric LOS, SSI, antibiotic
use in podiatric
surgery
Use of a SSC improves correct use of
antibiotics, reduces SSI’s, and reduces
LOS
Very low
Reames et al. (2015) [14] Retrospective
cohort
64,891/general SSI, wound
complications, all
complications, 30 day
mortality
Implementation of a checklist tool did
not affect adverse outcomes, potentially
due to failed implementation
Low
Table 40.1 (continued)
E.A. Sparks and H.T. Papaconstantinou
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455
Author/year Study design
n/type of
procedure Outcome measures Conclusions
Quality of
evidence
Loor et al. (2012) [15] Retrospective
cohort
5812/cardiac Reoperation for
bleeding
Implementation of SSC significantly
reduces operations for rebleeding
Moderate
van Klei et al. (2012) [16] Retrospective
cohort
25,513/general mortality SSC implementation reduces
in-hospital mortality, and effect is
related to checklist compliance
Moderate
Kim et al. (2015) [17] Retrospective
cohort
637/general Overall complications,
hypoxemia, adherence
to safety processes
SSC implementation at a resource-
limited hospital improves
communication, adherence to safety
processes, and complications with no
reduction in mortality. Improvements
were greater after two years than after 6
months
Low
Dell’Atti et al. (2013) [18] Retrospective
cohort
324/urologic All complications,
intrahospital mortality
SSC implementation led to a reduction
in overall complication rate and
mortality
Very low
Haynes et al. (2015) [19] Opinion n/a/general n/a Checklists are effective if barriers to
implementation are overcome
Very low
Garg et al. (2013) [20] Opinion n/a/general n/a Intraoperative crisis checklist is
perceived to fascilitate response to
massive hemorrhage
Very low
Ladak et al. (2014) [21] Opinion n/a/general n/a Perceived need for checklists to
improve preoperative workup and
planning
Very low
Panesar et al. (2009) [22] Opinion n/a/general n/a Adoption of SSC is effective and
should be adopted throughout the UK
Very low
40 Checklists in Surgery